Biomedical subjects

R Joseph Babaian

Publications and source records attributed to R Joseph Babaian.

16 recordsLinked to original sources

PubMed2006

The detection and potential economic value of complexed prostate specific antigen as a first line test.

PURPOSE: Prostate cancer detection is subject to a number of variables that can lead to unnecessary biopsies and associated costs. Measuring cPSA has been proposed as an alternative to tPSA for the early detection of prostate cancer. MATERIALS AND METHODS: Between November 1998 and April 2000, 1,362 men underwent transrectal ultrasound guided biopsies at 7 institutions. Of 1,243 evaluable men 467 with tPSA between 2.5 and 6.0 ng/ml, and normal digital rectal examination were analyzed. Statistical analysis used to compare cancer detection rates between PSA assays was performed using the Mann-Whitney U test. A separate group of 2,807 men who participated in a free cancer detection program was used to determine the current tPSA distribution and assess the economic impact of cPSA. RESULTS: Cancer was detected in 31.5% of the men (147 of 467) with tPSA between 2.5 and 6.0 ng/ml. Using a 2.2 ng/ml cPSA cutoff point detected 93.9% of cancers and would have avoided 20.3% of unnecessary biopsies in men with tPSA between 2.5 and 4.0 ng/ml. A 2.2 ng/ml cPSA cutoff point achieved an 11.9% overall decrease in the number of unnecessary biopsies in the tPSA range of 2.5 to 6.0 ng/ml with accompanying 98% sensitivity. The decrease in unnecessary biopsies is potentially associated with substantial health care cost savings. CONCLUSIONS: In the clinically relevant sensitivity ranges a 2.2 ng/ml cPSA cutoff point decreases the number of unnecessary biopsies and maintains higher specificity than a tPSA threshold of 2.5 ng/ml, illustrating the potential value of cPSA as a first line diagnostic test.

Biopsy↗

PubMed2005

Influence of anthropometric measurements, age, and prostate volume on prostate-specific antigen levels in men with a low risk of prostate cancer.

OBJECTIVES: To assess the correlation between age, height, body weight, body mass index, body surface area (BSA), prostate volume, and prostate-specific antigen (PSA) level, and to determine the significant factors for predicting the PSA level in men with a low risk of having prostate cancer. METHODS: Men who had undergone at least one ultrasound-guided extended prostate biopsy at the M.D. Anderson Cancer Center from 1998 to 2003 and were proven, on pathologic examination, to be without cancer were included in this study. All patients underwent clinical evaluations, including digital rectal examination, serum PSA determination, transrectal ultrasound examination, and anthropometric measurements. The relationship between the clinical parameters and PSA level was examined by the Mann-Whitney U test and determination of the Pearson correlation coefficient. RESULTS: A total of 653 men were eligible for analysis in our study. The median age was 62.0 years; the median prostate volume was 48.3 cm3; and the median PSA level was 5.5 ng/mL. The PSA level correlated with age (P < 0.001) and prostate volume (P < 0.001), but not with height, body weight, body mass index, or BSA. The prostate volume correlated with age (P < 0.001), body weight (P < 0.001), body mass index (P < 0.01), and BSA (P < 0.01), but not with height. Multivariate analysis revealed that prostate volume and BSA were significant factors for predicting the PSA level. CONCLUSIONS: Of the variables tested, prostate volume was most significantly related to the PSA level. The anthropometric parameters were not directly associated with the PSA level, but were associated with the prostate volume. Our findings suggest that differences in the PSA level may be influenced by body size, if the prostate volume is held constant in men with a low risk of having prostate cancer.

Age Factors↗

PubMed2005

Validation of criteria used to predict extraprostatic cancer extension: a tool for use in selecting patients for nerve sparing radical prostatectomy.

PURPOSE: We have previously reported that a prostate biopsy core specimen with a tumor length of at least 7 mm plus any positive basal biopsy core is the best predictor of extraprostatic extension (EPE) in radical prostatectomy (RP) specimens. We present prospectively collected data to validate our results. MATERIALS AND METHODS: The study included 270 patients who underwent RP for localized prostate cancer between January 2002 and December 2003 by a single surgeon. We correlated side specific biopsy data, pretreatment prostate specific antigen, clinical stage and RP type using pathological specimen data. RESULTS: Mean patient age was 59.6 years and median prostate specific antigen was 8.24 ng/ml. Of the patients 94 (35%) underwent unilateral and 114 (42%) underwent bilateral nerve sparing RP. The overall incidence of EPE was 16%. The incidence of EPE was 33% in patients who met our criteria vs 4.6% in those who did not. Of 538 evaluable sides 7.2% were positive at the surgical margin. The incidence of ipsilateral positive margins was 2.5% when the neurovascular bundle was spared according to our criteria vs 11.8% when the bundle was resected according to criteria. CONCLUSIONS: This series validates our finding that a prostate biopsy core with a tumor length of at least 7 mm plus a positive basal biopsy core of any length and tumor grade is predictive of ipsilateral EPE. In the absence of these criteria the incidence of ipsilateral positive margins is low. Thus, these criteria are valuable for predicting EPE and selecting patients for nerve sparing RP.

Aged↗

PubMed2005

The relationship between tumor volume and the number of positive cores in men undergoing multisite extended biopsy: implication for expectant management.

PURPOSE: We assessed the relationship between the number of positive cores obtained at extended biopsy and tumor volume in radical prostatectomy specimens as a tool for predicting the biological significance of prostate cancer from biopsy data. MATERIALS AND METHODS: The study group included 207 men who were treated with radical prostatectomy without neoadjuvant therapy at our cancer center. All patients were diagnosed by systematic extended biopsy (10 or 11 cores) performed between 1997 and 2003. The variables analyzed were patient age, prostate specific antigen, clinical stage, biopsy Gleason score, maximum tumor length in a core, greatest percent of tumor in a core, total tumor length, total percent of tumor in all cores, positive core location, initial or repeat biopsy and prostate volume in subgroups based on the number of positive cores, that is group 1-1, group 2-2 and group 3-3 or more cores. Bivariate correlation analysis and multiple logistic regression analysis were used to determine the predictors of insignificant cancer. RESULTS: The number of positive cores was significantly related to total tumor volume (r = 0.433, p <0.001). Insignificant prostate cancer (volume less than 0.5 cc and Gleason score 6 or less) was found in 21.7% of patients (45 of 207). The incidence of insignificant cancer was 42.5% (31 of 73 patients) in group 1, 16.4% (10 of 61) in group 2 and 5.5% (4 of 73) in group 3. There was a significant difference in the incidence of insignificant cancer among the subgroups (group 1 vs 2 p <0.001, group 1 vs 3 p <0.0001 and group 2 vs 3 p <0.05). The best model for predicting insignificant cancer in group 1 was the combination of tumor length less than 2 mm, Gleason score 3 + 4 or less and prostate volume greater than 50 cc with 83.9% sensitivity (26 of 31 patients) and 61.9% specificity (26 of 42). CONCLUSIONS: The probability of insignificant cancer was directly related to the number of positive cores. Tumor length in a core, Gleason score and prostate volume significantly enhanced the prediction model for insignificant cancer in men with 1 positive core who underwent extended biopsy.

Biopsy↗

PubMed2004

Can the number of cores with high-grade prostate intraepithelial neoplasia predict cancer in men who undergo repeat biopsy?

OBJECTIVES: To evaluate whether the presence of, or the number of cores containing, high-grade prostatic intraepithelial neoplasia (PIN) found in men who underwent initial extended multisite biopsy could predict which men would have prostate cancer on subsequent repeat biopsies. METHODS: Between June 1997 and January 2003, 1086 men underwent initial prostate biopsy for early detection of prostate cancer using an extended multisite biopsy scheme. Of these, 175 men without cancer underwent at least one repeat biopsy (range one to three; median interval between biopsies, 3 months). Among these 175 patients, 47 had high-grade PIN on initial biopsy. RESULTS: The initial extended biopsy identified cancer in 33.8% (367 of 1086) and high-grade PIN in 20.8% (226 of 1086). The incidence of high-grade PIN only in patients found to have cancer on initial biopsy was 29.7% (109 of 367). The presence of high-grade PIN was associated with concurrent prostate cancer at the initial biopsy (P <0.0001). Overall, repeat biopsy identified cancer in 18.3% of the 175 men. Of the 47 men with high-grade PIN, 5 (10.6%) were found to have cancer on repeat biopsy. The number of biopsy specimens positive for high-grade PIN on initial biopsy was not associated with the likelihood of prostate cancer on repeat biopsy. Multivariate logistic regression analysis showed that neither the presence of high-grade PIN nor the number of cores containing high-grade PIN on initial biopsy were predictors for prostate cancer on repeat biopsy. CONCLUSIONS: The number of cores positive for high-grade PIN was not predictive for cancer on repeat biopsy.

Adenocarcinoma↗

PubMed2004

Volume-based evaluation of serum assays for new prostate-specific antigen isoforms in the detection of prostate cancer.

OBJECTIVES: Recently, disease-specific isoforms of the prostate-specific antigen (PSA) have been identified. We evaluated the efficacy of precursor isoforms of PSA (pPSA) and an internally cleaved form of PSA referred to as the benign prostatic hyperplasia-associated PSA (BPSA) for the detection of prostate cancer. METHODS: Serum concentrations of [-2], [-4], and [-7]pPSA, sum pPSA ([-2] + [-4] + [-7]pPSA), and BPSA were retrospectively measured in 43 selected men. The median total PSA levels in men with and without cancer were 6.5 microg/L (range 0.4 to 12.1 microg/L) and 6.1 microg/L (range 3.7 to 21.5 microg/L), respectively. Of the 43 men, 15 had clinical T2 prostate cancer with an ultrasound-estimated prostate volume (PV) of greater than 50 mL, 13 had clinical T2 prostate cancer with PV less than 25 mL, and 15 were prostate cancer free with PV greater than 50 mL. RESULTS: The median values for BPSA, free-to-total PSA ratio (f/tPSA), and benign-to-total PSA ratio (B/tPSA) differed statistically between men with cancer and a PV less than 25 mL and men with cancer and a PV greater than 50 mL (P <0.05) and between the men with cancer and a PV less than 25 mL and men without cancer and a PV greater than 50 mL (P <0.005). All evaluated variables had no correlation with tumor volume in 15 men who had undergone radical prostatectomy. CONCLUSIONS: In this preliminary study, the level of [-2], [-4], sum pPSA, and BPSA seemed to be PV related, but only BPSA and B/tPSA and f/tPSA were significantly associated with PV. Therefore, pPSA did not aid in better discriminating cancer from noncancer.

Adenocarcinoma↗

PubMed2004

Update on prostate biopsy technique.

PURPOSE OF REVIEW: Over the past decade, a considerable number of modifications have been made to the techniques for prostate cancer biopsy. In this review, we discuss the developments reported in the literature since January 2003. RECENT FINDINGS: The addition of laterally directed biopsies has enhanced the diagnostic performance of the conventional sextant biopsy approach. Several models of the extended biopsy technique have been introduced that increase the number of cores by combining sextant and lateral biopsies to enhance the cancer detection rate. Several reports have shown that the cancer detection rate decreases as prostate volume increases, compared with an increasing cancer detection rate on repeat biopsy in men with large prostate gland volumes. Other studies have shown that the percentage of positive cores and the total percentage of tumor found at biopsy are significant independent predictors of pathological outcome on multivariate analysis. In randomized, double-blind studies, infiltration of the neurovascular bundles with lidocaine significantly reduces pain associated with extended biopsies. SUMMARY: Current reports have suggested that: (1) extended biopsy schemes decrease the false-negative rate compared with conventional sextant biopsy; (2) laterally directed biopsies from the anterior horn should be included in extended biopsy protocols; and (3) local anesthesia reduces pain associated with extended biopsy.

Biopsy↗

PubMed2004

Tumor length and location of cancer on biopsy predict for side specific extraprostatic cancer extension.

PURPOSE: We studied preoperative variables in a contemporary series of men who underwent nonnerve sparing radical prostatectomy in an effort to establish criteria that would predict side specific extraprostatic extension (EPE) of cancer. MATERIALS AND METHODS: We reviewed the records of 430 patients who underwent radical prostatectomy for localized prostate cancer with no prior therapy between 1996 and 1998, and for whom we had at least sextant biopsy information. We evaluated biopsy data (Gleason score, maximum length of cancer in positive cores, percent of cancer per involved core, proportion of positive biopsy cores, tumor location and number of positive biopsy cores) and correlated these findings with EPE at the neurovascular bundle and posterior lateral (NVB/PL) region. RESULTS: We found that a higher number of positive cores, a higher biopsy Gleason score on a side, a positive core at the basal region, 50% or greater tumor in the core or a maximum tumor length of 7 mm or greater increased the likelihood that EPE was present at the NVB/PL region on the corresponding side of the prostate. On multivariate analysis maximum tumor length 7 mm or greater and positive basal core location were the strongest independent predictors of EPE at the NVB/PL region on a given side (p <0.0001 and 0.002, respectively). CONCLUSIONS: Excluding any patient with 1 positive biopsy core with a maximum tumor length of 7 mm or greater plus a positive basal core of any tumor length and grade can decrease the risk of EPE at the NVB/PL region to approximately 10%.

Biopsy↗

PubMed2004

A comparison of extended biopsy and sextant biopsy schemes for predicting the pathological stage of prostate cancer.

PURPOSE: We compared the performance of the extended multisite directed biopsy strategy to the sextant component of this strategy for predicting the pathological stage and Gleason score of the radical prostatectomy specimen. MATERIALS AND METHODS: We studied 157 men in whom prostate cancer was diagnosed by extended multisite directed biopsy and who underwent radical retropubic prostatectomy. The pretreatment variables of serum prostate specific antigen, prostate specific antigen density, biopsy specimen Gleason score, the location, number and percent of cancer containing cores, greatest tumor length in a single core and greatest percent of tumor in a single core were determined and compared with the pathological features of prostate cancer in the radical prostatectomy specimens. A comparison of the information obtained from sextant component cores of the extended biopsy strategy with that from all cores of the extended biopsy strategy was performed using chi-square statistics and ROC curve analysis. RESULTS: When comparing the areas under the ROC curves, the extended multisite directed biopsy strategy was found to have greater predictive power for extraprostatic extension than the sextant core component of this biopsy scheme, although the difference was not significantly different. The sextant component was equivalent to the extended biopsy strategy for predicting the prostatectomy specimen Gleason score. CONCLUSIONS: The extended biopsy strategy has better performance in the upper sensitivity ranges compared to the sextant technique for predicting extraprostatic extension.

Biopsy↗

PubMed2003

A streamlined three-dimensional volume estimation method accurately classifies prostate tumors by volume.

Prostate tumor volume has been suggested to be an important pathologic variable that predicts for clinical significance and outcome. However, the determination of tumor volume using standard methods such as computerized planimetry or image analysis is labor intensive. We studied whether length (L), width (W), and height (number of cross sections x sectional thickness, CST) of a tumor focus could be used to estimate prostate tumor volume. We studied 1091 tumor foci from 365 selected serially sectioned radical prostatectomy specimens. We randomly divided the specimens into evaluation (182 specimens) and validation (183 specimens) groups. After analyzing the evaluation group, we derived the formula 0.4 (slope of the regression line) x L x W x CST to estimate volume. We then tested whether our three-dimensional volume estimation formula could accurately classify tumor volume for specimens in the validation set as insignificant (</=0.5 cm3) or significant (>0.5 cm3), and also into a five-category tumor volume scheme. Our three-dimensional estimate accurately classified tumors into insignificant and significant total volume categories in 94.0% of cases and into the five-category scheme in 85.8% cases. These accuracy rates were significantly better than rates for other methods. The three-dimensional estimate is an accurate and straightforward method for assessing prostate tumor volume.

Body Weights and Measures↗

PubMed2003

The predictors of pelvic lymph node metastasis at radical retropubic prostatectomy.

PURPOSE: We studied preoperative variables in a contemporary series of patients who underwent radical retropubic prostatectomy (RRP) to determine which variables were associated with lymph node metastasis. MATERIALS AND METHODS: Between January 1995 and November 1999, 1,091 men underwent RRP, 695 of whom underwent bilateral pelvic lymph node dissection without any prior therapy. We evaluated biopsy Gleason score, maximum tumor length and maximum percentage of tumor in the positive core(s), location and number of positive cores, and total prostate specific antigen before surgery in 295 of these patients. We also developed a classification and regression tree analysis algorithm to segregate the risk of positive lymph node metastasis. Stepwise logistic regression analyses were used to determine independent predictors of lymph node metastasis. RESULTS: Of the 695 patients 19 (2.7%) had lymph node metastasis. Clinical stage, Gleason score, positive basal core, greatest percentage of tumor on positive cores and maximum tumor length in positive core were significant predictors of lymph node metastasis in the Mann-Whitney U test and chi-square test. Classification and regression trees analysis revealed that 4 or more positive cores with any Gleason grade 4 or 5, serum prostate specific antigen 15.0 ng/ml or greater, or the presence of dominant Gleason 4 or 5 were independent predictors of lymph node metastasis. Our algorithm had a significantly higher diagnostic performance than the Hamburg algorithm (p = 0.002). CONCLUSIONS: Our algorithm may be a valid tool for the prediction of lymph node metastasis and may help to select men who do not need to undergo bilateral pelvic lymph node dissection with RRP.

Adult↗

PubMed2002

Clinical efficacy of prostate cancer detection using power doppler imaging in American and Japanese men.

PURPOSE: The aim of this study was to compare the detection rates of tumor vascular flow as measured by power Doppler imaging (PDI) in 2 populations and to determine whether PDI can reduce the number of unnecessary prostate biopsies in men with serum prostate-specific antigen (PSA) concentrations less than 10.1 ng/ml. METHODS: The patient populations were Japanese (group 1) and American (group 2) men with either serum PSA concentrations of 4.1-10.0 ng/ml or abnormal findings on digital rectal examination (DRE) plus PSA concentrations less than 4.1 ng/ml. We compared the overall diagnostic accuracy of DRE, gray-scale transrectal sonography (TRUS), and PDI between the 2 groups. RESULTS: In total, 275 men were studied, 154 in group 1 and 121 in group 2. Cancer was identified in 27% of men in group 1 and in 60% of group 2. Men with cancer in both groups differed significantly in age, peripheral zone volume, and mean number of positive biopsy cores. The sensitivity and specificity of PDI in group 2 were significantly inferior to those in group 1. The negative predictive value (NPV) of PDI was significantly higher for group 1 than for group 2. The NPV of PDI in group 1 was equivalent to that for the combination of DRE and TRUS, whereas the NPV for PDI in group 2 was significantly inferior to that of DRE and TRUS. CONCLUSIONS: Tumor vascularity could be detected by PDI more effectively in Japanese men with cancer than in American men with cancer. We hypothesize that this difference was a result of larger cancer volumes and smaller prostates in the Japanese men. PDI did not provide any performance advantage over DRE and TRUS in avoiding unnecessary biopsies.

Adult↗

PubMed2002

Comparative analysis of complexed prostate specific antigen, free prostate specific antigen and their ratio in detecting prostate cancer.

PURPOSE: We evaluate the diagnostic use of total, free and complexed serum prostate specific antigen (PSA), and their ratios for enhancing the specificity in detecting prostate cancer. MATERIALS AND METHODS: A total of 354 nonconsecutive men undergoing prostate biopsy were eligible for this retrospective and prospective study. Cancer was found in 122 of these 354 men (34%). Receiver operating characteristics curve analyses were used to calculate and compare the performance of total PSA (Hybritech, San Diego California and Bayer, Tarrytown, New York), complexed PSA (Bayer), percent complexed PSA and percent free PSA. In addition, sensitivity and specificity were calculated and compared. RESULTS: The area under the receiver operating characteristics curve was highest for percent free PSA, followed by percent complexed PSA, complexed PSA and the 2 total PSA assays (Hybritech and Bayer). The cutoff value of 3.45 ng./ml. for complexed PSA detected the same number of cancers and resulted in 1 additional false-positive case compared with a Hybritech total PSA threshold of 4.0 ng./ml. At sensitivities of 80% to 95%, there were no significant differences for detection comparing the corresponding specificities between Hybritech total PSA and complexed PSA for all 354 men. Complexed PSA alone did not enhance the overall diagnostic accuracy compared with percent free PSA in the Hybritech total PSA range between 4.01 and 6.00 ng./ml., between 6.01 and 10.00 ng./ml., and between 2.50 and 6.00 ng./ml. At sensitivities of 80% to 95% specificity of percent complexed PSA was almost identical to that of percent free PSA except for the Hybritech total PSA range less than or equal to 4.00 ng./ml. CONCLUSIONS: This study suggests complexed PSA is equivalent to total PSA for the early detection of prostate cancer. Percent free PSA outperforms complexed PSA and percent complexed PSA performed equivalently to percent free PSA in all total PSA ranges analyzed between 2.5 and 10 ng./ml.

Aged↗

PubMed2002

Predictors of cancer in repeat extended multisite prostate biopsy in men with previous negative extended multisite biopsy.

OBJECTIVES: To evaluate the factors influencing the cancer detection rate in men whose initial and repeat biopsies were both performed using an extended multisite biopsy scheme. Sextant biopsy of the prostate is associated with a significant false-negative rate, as evident from the high cancer detection rate after repeat prostate biopsy. Extended multisite biopsy schemes have therefore been recommended to maximize cancer detection. METHODS: Between June 1997 and August 2001, 939 men underwent prostate biopsy for early detection of prostate cancer using the extended multisite scheme (10 or 11 cores incorporating the anterior horn of the peripheral zone with or without midline peripheral zone and/or the transition zone). Of these 939 men, 89 (9.5%) underwent a repeat extended multisite prostate biopsy. The median prostate-specific antigen level was 6.9 ng/mL (range 0.7-36.1). Twenty-four men (27%) had an abnormal digital rectal examination at presentation. Most men (86%) in the group undergoing repeat biopsy had two or more risk factors for a positive biopsy. The median interval between biopsies was 4 months. RESULTS: Of the 89 men, 15 (17%) had prostate cancer in the repeat biopsy specimen. Seven cancers (47%) were found only in the alternate biopsy sites, 5 (33%) cancers were found only in the sextant sites, and 3 in both sextant and alternate sites. Cancer was present in only one biopsy core in 11 (73%) of the 15 men, and the median Gleason score was 6 (range 6-8). On multivariate analysis, the presence of atypical glands suspicious for carcinoma (AGSC) was the only independent predictor of cancer in repeat biopsy (P <0.004). Of the 79 men without AGSC in the initial biopsy, 8 (10%) had a positive repeat biopsy. The total and percent free prostate-specific antigen level, digital rectal examination, ultrasound findings, and presence of high-grade prostatic intraepithelial neoplasia were not predictive of cancer detection. CONCLUSIONS: The probability of a positive result for a repeat prostate biopsy is lower after an initial extended multisite biopsy compared with an initial sextant biopsy. The presence of AGSC was the only significant predictor of cancer in the repeat biopsy. Because nearly 50% of cancers detected in the repeat biopsy were in alternate sites only, using a sextant biopsy scheme for repeat biopsy would have missed these cancers.

Adult↗

PubMed2002

Outcome of patients with Gleason score 8 or higher prostate cancer following radical prostatectomy alone.

PURPOSE: We determine the effect of clinical and pathological variables on the outcome of patients with prostate cancer of Gleason scores 8 or greater treated with radical prostatectomy alone. MATERIALS AND METHODS: Between April 1987 and October 1998, 1,199 patients underwent radical retropubic prostatectomy. We identified 188 patients assigned a Gleason score of 8 or higher in the prostatectomy specimen who did not receive any neoadjuvant or adjuvant therapy. Median followup was 60 months (range 1 to 129). Disease recurrence was defined as any detectable prostate specific antigen level 0.1 ng./ml. or greater. RESULTS: Of 188 patients 128 (68%) had no evidence of prostate cancer after a median followup of 60 months, while 60 (32%) demonstrated a detectable PSA level. There were 58 (31%) patients with disease confined to the prostate with negative surgical margins while 108 (57%) had prostate cancer confined to the surgical specimen. Positive surgical margin with extraprostatic extension was seen in 16 (9%) patients and seminal vesicle invasion was present in 40 (21%). The 5 and 7-year disease-free survival rates for the entire cohort were 71% and 55%, respectively. Patients with specimen confined disease had a significantly higher 5-year disease-free survival rate than those with nonspecimen confined disease (84% and 50%, p <0.0001). On multivariate analysis pathological status of the surgical specimen was the most significant independent predictor of disease recurrence. Age, ethnicity, clinical stage and preoperative PSA had no independent effect on disease recurrence. CONCLUSIONS: Long-term disease-free survival can be expected in those patients with high grade prostate cancer whose disease is confined to the prostate and/or the surgical specimen.

Aged↗

PubMedDate not supplied

Role of systematic ultrasound-guided staging biopsies in predicting extraprostatic extension and seminal vesicle invasion in men with prostate cancer.

PURPOSE: To assess the presence of extraprostatic extension and seminal vesicle invasion in men with prostate cancer, we performed systematic staging biopsies targeting neurovascular bundles, seminal vesicles, and other extraprostatic tissues before the men underwent radical prostatectomy. We retrospectively evaluated the clinical efficacy of these systematic staging biopsies compared with digital rectal examination (DRE) and transrectal sonography (TRUS). METHODS: Two hundred forty-four candidates for prostatectomy who had a diagnostic biopsy Gleason score of 8 or higher and/or indications of extraprostatic extension (eg, seminal vesicle invasion) by DRE or TRUS underwent staging biopsies using an 18-gauge Tru-Cut needle under real-time TRUS guidance between June 1997 and March 2000. We determined the number of staging biopsy cores to be taken based on the Gleason score of the diagnostic biopsy as well as abnormal DRE and/or TRUS findings. The chi-square test was used to evaluate the statistical significance of differences. RESULTS: There were no complications of staging biopsy. In 75 (31%) of the 244 patients, results of the staging biopsies were positive. The clinical stage was upgraded by staging biopsy in 18 (24%) of these 75 patients. After the staging biopsies, 90 patients underwent radical prostatectomy. Among these 90 patients, staging biopsy specimens were positive for cancer in 20 (47%) of the 43 patients who received neoadjuvant therapy and in 1 (2%) of the 47 patients who did not receive neoadjuvant therapy. There were no false-positive staging biopsies in either group. Among the 90 patients who underwent radical prostatectomy, the false-negative rate for the prediction of organ-confined disease was 43% (30/69) for staging biopsies compared with 29% (10/34) for TRUS. The diagnostic accuracy of staging biopsies (67%; 60/90) was higher than that of DRE (52%; 47/90; p < 0.05) but lower than that of TRUS (79%; 71/90; p = 0.066). CONCLUSIONS: Staging biopsies can reliably sample extraprostatic tissue, including the seminal vesicles and neurovascular bundles. Positive staging biopsy results can aid in the selection of treatment options and in the prediction of outcome for individual patients by providing definitive histologic confirmation of locally advanced disease. Conventional predictive variables for staging can be applied when the results of staging biopsies are negative.

Aged↗